MDM 626-00-42E

GUDID 04546540666017

Liner- Cementless

Howmedica Osteonics Corp.

Acetabular shell

• Primary Device ID: 04546540666017
• NIH Device Record Key: 9e9f3e94-a06d-4cbe-9bae-ef49f20e28b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDM
• Version Model Number: 626-00-42E
• Catalog Number: 626-00-42E
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 42 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540666017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103233

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [MDM]

• 04546540666062: Liner- Cementless
• 04546540666055: Liner- Cementless
• 04546540666048: Liner- Cementless
• 04546540666031: Liner- Cementless
• 04546540666024: Liner- Cementless
• 04546540666017: Liner- Cementless
• 04546540666000: Liner- Cementless
• 04546540665997: Liner- Cementless